About this agent
What does the Regulatory Affairs Specialist agent do?
Prepares and reviews medical-device regulatory documentation, classification, clinical evaluation, post-market surveillance and notified-body submissions.
Which AI tools does the Regulatory Affairs Specialist agent work with?
Claude Code, Codex, Cursor, GitHub Copilot and Gemini CLI. Claude Code reads its skills from .claude/skills, and the other tools read the same skills from .agents/skills.
How many skills does the Regulatory Affairs Specialist agent have?
The Regulatory Affairs Specialist agent has 18 skills.
How do I get the Regulatory Affairs Specialist agent?
Sign in to Prompeteer and download it as one ZIP file. The ZIP holds one folder, regulatory-affairs-specialist-agent, with an AGENTS.md brief and the agent's skills. Open that folder as a project in your AI tool. A team download holds one folder per agent.
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Skills Hub
Browse the Skills Hub for single skills, or read about the Agent Skills format.